Clinical Performance and Immediate Child and Parental Satis-faction With BioFlx Crowns in Primary Molars: A Prospective, Single-Arm, Non-Randomized Interventional Study

King Abdulaziz University28 enrolled

Overview

Informed consent was obtained from the parents/guardians of participating children after a detailed explanation about the treatment along with possible outcomes, risks, benefits, and discomforts is provided. In addition, assent forms were obtained from the participating children who are seven years and older. Healthy children or children with mild, stable systemic medical conditions, who were cooperative and required at least one full-coverage restoration in a primary molar were recruited from the pe-diatric dentistry clinics at King Abdulaziz University Faculty of Dentistry. BioFlx crowns were placed by trained pediatric dentistry residents under a consultant's supervision. Immediately after crown cementation, proximal contact and occlusion were recorded. At three- and six-month fol-low-up visits, clinical outcomes evaluated were the proximal contacts, occlusion, crown retention, staining, wear of the opposing tooth, marginal integrity, and any changes in the crown material surface. In addition, plaque accumulation and gingival health around each crowned tooth were assessed at the tooth level. Immediate post-treatment satisfaction of children and their parents was assessed following crown cementation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dental Caries

Interventions

Eligibility

Sex: ALLMin age: 6 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy children or with mild stable systemic medical condition such as controlled asthma, Age 6 to 9 years * Cooperative * One primary molar that requires a full-coverage restoration with at least one proximal contact with the adjacent tooth * No clinical or radiographic signs or symptoms of periradicular pathology * Normal interproximal bone levels * No more than one-third root resorption radiographically Exclusion Criteria: * Children with severe malocclusion * Children with periodontal disease * Children requiring comprehensive dental treatment under general anesthesia.

Outcomes

Primary Outcomes

Clinical performance

Before preparation, participant-level baseline data were recorded, including dental history and a comprehensive preoperative full-mouth oral health assessment comprising dental caries experience recorded using the dmft/DMFT indices, oral hygiene using the Greene and Vermillion Simplified Oral Hygiene Index (OHI-S), and gingival health assessed using the Löe and Silness Gingival Index. Furthermore, the clinical assessment comprised multiple parameters, including selected criteria adapted from the modified United States Public Health Service (USPHS) system for the direct clinical evaluation of restorations \[16\], namely marginal integrity and crown staining; crown-specific clinical criteria adapted from Donly et al., namely proximal contact, occlusion, crown retention, and wear of the opposing tooth; established plaque accumulation and bleeding on probing and a study-specific criterion for evaluating the surface integrity of BioFlx crowns.

Time frame: 6 months

Secondary Outcomes

child and parental satisfaction

Child and parental satisfaction survey.The questionnaire encompass an individual interview with the children and their parents/guardians in a separate setting. The participants were asked to indicate their satisfaction with the crown color, shape, size, and overall appearance on a Likert's scale from one to ten, in which one indicates very satisfied/very acceptable and ten indicates not satisfied at all/ not acceptable at all.

Time frame: immediate post treatment